ART will also cover that open new horizons in the biomedical field, particularly in the field of new transplants, such as cell and tissue transplants.
Tissue Banks have a duty to acquire, store and distribute tissue certifying their suitability and safety (Dir.2004/23/CE). their catchment area is optimally about 18 million inhabitants.

At present they are distributed throughout the country and insufficient in number and especially at least geographically concentrated, in fact, their position does not go beyond Florence, thus bringing out a two-speed nation, with all the banks are currently authorized concentrated north of Florence. The Directive of the European Parliament of 3.31.2004 and the Council of Europe 's Regions recommends proceeding with the establishment of these centers of high technology or consortium of their own or, if the basin' s audience insufficient, dictating the rules for processing, preservation, storage, and function of human tissues and cells (GMP). The regions should have applied this provision by April 2006, so it is even desirable that many regions in central and southern, may the Convention to meet with European directives and launch development programs more responsive to needs of the area and cost.
If we consider then the increase in average age, the incidence of chronic diseases such as diabetes and chronic vascular insufficiency, the need for new and more appropriate treatments explains the need to develop therapeutic approaches in advanced multifunctional structures and multidisciplinary.
In addition, the chronic character developed from some diseases of the obvious increase in life expectancy of the population has an impact on the NHS with a very high cost, divided among three sectors: hospital, primary care and treatment programs; these, indirectly, add the days of absence from work due to illness (Allegra C., Current Medical Research and Opinion 2003).
In recent years, raising the average age of the population in Western countries is proportional to the increase in the incidence of degenerative diseases of various tissues and organs. At the base there are, on the one hand a major arc of life at the disposal of the disease to manifest itself, the other intrinsic tissue deficiency linked to aging of both cellular and extracellular components. The regeneration of these components is, in most tissues, extremely low or limited to specific conditions. In the therapeutic strategy of these diseases can now be realistically a possibility provided by the stem cells, and other biotherapeutics.
Existing law classifies living cells manipulated in vitro to perform functions therapeutic, diagnostic or preventive medicinal products in man as in all respects. This classification means that these products, whether used as products for clinical research or other clinical performance for various reasons, are manufactured in facilities licensed by the competent authority (Italian Drug Agency, AIFA). The workshop production must meet the criteria established by the European Guidelines for Good Practice (GMP) for sterile medicinal products by inoculation.
Since the entry into application of European regulation on medicines for advanced planned 1 January 2009 all advanced medicinal products, (somatic cell therapy, gene therapy and tissue engineering) will be produced by authorized personnel.
The structure in addition to the Bank for the storage and release of soft tissues like skin and will have a workshop or mobile workshop, the center of Pharmaceutical Manufacturing suitable for manipulation of cells and tissues under sterile conditions for the preparation of advanced medicinal products, both experimental and established . It is a facility authorized in accordance with directives on the production of medicinal products (06.15.1991 DL178's). The presence of a laboratory culture of the skin, which also does research, provides technologically advanced treatment for serious illnesses such as severe burns (70% of body surface area burned to the 3 rd degree), without the skin grafts have not grown chances of survival, diabetic foot ulcers and torpid. The latter now have an expense that goes back to 3% of national health expenditure, without remission of the disease seriously disabling while the skin graft healing in a cultivated ensures a high percentage of cases.
Today, the region pays the import structures of skin from outside the region at a cost diluted in the chapters, but with the Lazio region, the bank would have a high quality product controlled, more reliable and could supply the entire South Central that is devoid of a this laboratory, GMP approved according to the parameters required by Europe. So not only would represent a saving for the Lazio Region, but it would be a reference to non-therapeutic alternative for emerging diseases and rising as burns, diabetic foot ulcers and compression.
In a 2005 study on diabetes type II (De Berardis G. et al, J Diabetes Complications 2005) that involved 3564 patients from different centers throughout the country, has shown an incidence of 6.8% of complications leg ulcers and 50% of nontraumatic amputations occurred only in patients with diabetes. In 2000 he resigned with a diagnosis of diabetes in primary or secondary 952/100000 amounted to Lazio, with costs borne by the NHS for patients with macrovascular complications of around 4143 euros.
The hospitalization rate for DRGs related to lower limb amputations was 6 / 100000. (Regional Health Plan, 2002-2004, Official Bulletin of the Lazio Region, No. 24, August 30, 2002).
In this panorama you add up the admissions for burns.
In 2006 there were in fact made, at the center of Big Burns' hospital S. Eugenio in Rome, which collects and burns from Rome Lazio, Abruzzo and Molise, 342 hospitalizations for burns, 86 pediatric patients, 256 adults, foreigners and of these 87, 6 coming from other states. The interventions of high and medium surgery were a total of 441, 13 of these made for skin grafts from cadavers, transplant of autologous keratinocytes for 20 and 22 for cell transplantation autologous epidermal-dermal space. More than 5225 were the outpatient services. Mortality was reduced from 13% to 7.5% despite the progress in the average.
Currently, major burns at the center for about a year is not made the request of keratinocytes (skin cultivated), and because of the problems of waiting times and costs high.
In burns over 40% of body surface area with 3 rd degree burns require a skin graft grown within 20 days of a layer of cadaver skin.
The cost of 10 cm2 of skin cultivated has increased from 500-700 euro 2500-3000 euros.
In a person of average height for 40% of body surface area burned correspond to 800 cm2, so you need 80 pieces of 10 cm 2 (2500 x 80 = Euro 200,000.00). We must consider that in a year in the burn center of St. Eugene is at least 20 hospitalized with burns burns involving at least 40% of body surface area, which imply a cost of 4,000,000 euros.
Currently it is not used at the burn center of St. Eugene Skin cultivated, except in some cases, that is not the most modern therapy and who has the most successful both as a lifesaver for both the quality of life of patients burns.
It uses alternative techniques, but of lower quality and effectiveness for the following reasons:
- Prices too high
- Very long waiting times, before it can be put into culture biopsy
passes a month, then the culture takes about three weeks, so you have to wait more than 50 days
- Transport often pollutes the skin, and therefore can not be used.
As already noted the bank intended to give the skin the skin grown for other diseases such as indolent ulcers, bed sores, diabetic foot, trauma with loss of large areas of skin, which are now, with the traditional medications, a charge of 5% of the total national health expenditure.
In addition, the workshop or laboratory authorized for GMP in tissue cultures used to revitalize other tissues for grafting such as cornea and bone, then you also support the bank to the bank of the cornea and skeletal muscle.
This workshop will develop the GMP production of other tissues, such as heart valves, blood vessels, and research into the use of stem cells on solid tumors.
The management may be at no cost to the region if it relies on a consortium that combines public bodies and private entities.
The factory is GMP support in a word the whole Regenerative Medicine, which has already begun as therapy, but that will have a development especially in the near future.
The workshop GMP is also a source of advanced research centers connected with the best international industry, but which can give hospitality to those researchers intend to devote to cell and tissue cultures, especially our young researchers.
Although the major limitation for the application of advanced medicinal products is their cost, it is offset, however, the type of intervention, designed, adapted and targeted to the individual so as to obtain a timely intervention and often decisive, and no sequelae with greater care in restitution ad integrum of the psycho-physical person.
Not to mention the lack of facilities for production and lack of interest of big industry in the development of pharmaceutical products that remain niche. At present, the skin samples are sent to a private company, Abano Terme (Padova) is the only one in Italy can produce the skin expands the authorized structures.
In this framework fits the need to develop multi-functional structures in the Lazio Region and multidisciplinary mix of public and private companies, to overcome deficiencies and mutual amplification of individual advantages: low investment, lack of entrepreneurial and appropriate quality systems, the absence of a chain decision-ready and responsive to emerging needs in the public sector, are widely supported by the availability of flexible resources, rapid decision-making capacity, dall'agile scientific advancement and the ability to respond to technological change the private sector.
The new centers in the developing world are based on collaboration among different sectors of government agencies that provide a solid experience in the management of the patient / donor, increased availability of biological material and the excellence of research groups, and private entities.

Advantage of collaboration with private industry sector
The implementation of multifunctional structures requires the combination of public and private companies to overcome each other's failings and the amplification of individual benefits.

FOR THE PUBLIC
Weaknesses:
1. Underinvestment
2. Entrepreneurial mentality and quality systems to create
3. Difficult decision-making chain
Strengths:
1. Experience in proper management of donor
2. Availability of raw materials
3. Excellence of research groups
SOCIETY FOR THE 'PRIVATE
Weaknesses:
1. Lack of know-how
2. Poor availability of "raw material"
Strengths:
1. Flexible resources
2. Quick decisions
3. Agile scientific progress and response to technological change.

Therefore, resorting to the public and the private initiative becomes more reliable.
Based on this would be the Lazio Region to have a center, production, storage and release and research, with very low cost and meets the therapeutic needs of patients would not otherwise be treatable, as well as specific European directives, placing itself as leader of the Regions Center -Southern, with a central competitive at European level, both in terms of clinical science.
Regarding this last aspect must be remembered that side of the shop, GMP compliant, it is planned to take place in stem cell research applied to soft tissue grafts, and tissue repair and regeneration, and for cell therapy. The facility dedicated to research and development projects funded will be carried out by national and European structures, and sometimes the translation is in the clinic and regenerative surgery is the development and production of patents.
This new perspective is now defined as a whole by the term medical repair or regeneration (regenerative medicine, tissue repair) in the Anglo-Saxon literature and whose approach has to be updated according to parameters, first of all knowledge and multidisciplinary studies and the need to creation of multidisciplinary teams.
Finally, this project is part of the package for its quality indicators approved by the State-Regions Conference, as a condition of health.
Therefore, the Bank of the skin, soft tissue stem cells and workshop as well as being an investment for the treatment of serious diseases, it is also a promotion for a cutting-edge research and is a response to the State Conference of the Lazio Region - Regional and Europe .

Also this year you have a unique opportunity to help those who are on the waiting list to regain his life and the quality of life.

The 5xmille does not replace the 8xmille (for religious denominations) and does not represent an additional expense to the taxpayer.
  And 'share of taxes to which the state gives to direct it to the non-profit organizations such as the Regional Agency of Lazio for Transplantation and related disease.

Transform your tax return in a great act of concrete solidarity for those who must regain his life and the quality of life.
You will help us to welcome and help more people are waiting for a transplant.

Here's how:
1. Signature in the box dedicated to the donation of 5 X 1000
2. Report of the tax code 'Agency of the Lazio Regional Transplant and related disorders:
08054201002

Here are illustrations of the various models.